MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM TTS STANDARD TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	ST16CN70NSC120N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received that a smiths medical bivona custom tts standard tracheostomy tube cuff leaked while in use at the patient's home.Subsequently, a tracheostomy (trach) change out was required and the patient recovered.No clinical consequences to the patient were reported.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Visual inspection of the device has confirmed the reported customer complaint.A 15mm tear was observed below the cuff band.The appearance of the tear appeared to resemble cuffs that have been over-inflated.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: BIVONA CUSTOM TTS STANDARD TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8263029
• Report Number: 3012307300-2019-00182
• Device Sequence Number: 16664428
• Product Code: JOH
• UDI-Device Identifier: 15019517046632
• UDI-Public: 15019517046632
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ST16CN70NSC120N
• Device Catalogue Number: ST16CN70NSC120N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 03/19/2016
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention